NCT04168775

Peak Inspiratory Flow Rates in Patients With COPD

A Single Center, Open Label, Prospective Study Measuring Proportion of Patients With Suboptimal Peak Inspiratory Flow Rate (sPIFR) Over 24 Weeks in an Ambulatory Setting Among Moderate to Very Severe COPD Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Recent studies have reported that some Chronic Obstructive Pulmonary Disease (COPD) patients may have a suboptimal ability to generate a sufficient inspiratory effort to achieve adequate lung delivery of inhaled medications through dry powder inhalers. Sparse data is available about the inspiratory capacity of these patients in the home setting, whether clinically stable or when experiencing worsened respiratory symptoms outside the acute care setting. This study is undertaken to better understand the proportion of patients with suboptimal peak inspiratory flow rate (sPIFR) measurements amongst COPD patients receiving dry powder inhaler(s) (DPI) in the ambulatory setting. Further, the study will characterize PIFR over time, the variability of PIFR measurements, and the associations with potential predictors (demographics, clinical, Patient-Reported Outcomes (PRO), body position, and device) as well as exacerbations frequency and change in PIFR around period of exacerbation.

Detailed description

Recent studies have reported that some COPD patients may have a suboptimal ability to generate a sufficient inspiratory effort to achieve adequate lung delivery of inhaled medications through dry powder inhalers. Sparse data is available about the inspiratory capacity of these patients in the home setting, whether clinically stable or when experiencing worsened respiratory symptoms outside the acute care setting. This study is undertaking this study to better understand the proportion of patients with suboptimal peak inspiratory flow rate (sPIFR) measurements amongst COPD patients receiving dry powder inhaler(s) (DPI) in the ambulatory setting. Further, the study will characterize PIFR over time, the variability of PIFR measurements, and the associations with potential predictors (demographics, clinical, PRO, body position, and device) as well as exacerbations frequency and change in PIFR around period of exacerbation. To complete these aims, 120 participants will be enrolled in a 6 month study to perform PIFR measurements and respiratory questionnaires at home.

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	Home PIFR monitoring with InCheck Dial	The In-Check G16 DIAL® (Alliance Tech Medical, Granbury TX) is a simple hand-held device that measures PIFR via a brief inspiratory maneuver.

Timeline

• Start date: 2019-07-31
• Primary completion: 2022-04-26
• Completion: 2022-04-26
• First posted: 2019-11-19
• Last updated: 2022-09-21
• Results posted: 2022-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study